Clinical Study to check the Skin Safety and Efficacy of Aloe Wound Healing Ointment for Wound Healing.
- Conditions
- Health Condition 1: R238- Other skin changes
- Registration Number
- CTRI/2023/11/059901
- Lead Sponsor
- niversity of Pretoria
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
1. Subjects who agree to have their wound photographed during the trial.
2. Healthy Male and Female subjects of 18 to 50 years of age.
3. Subjects having acute wounds (less than 24 hours of occurrence).
4. Subjects with superficial skin wound and partial thickness skin wound greater than or equal to 1.0 and less than or equal to 16.0 cm² area.
5. Subjects who can be categorized under Stage I and Stage II wound.
6. Subjects ready to take injection TT before application of study drug.
7. Subjects are willing to make all required study visits.
8. Subjects are willing to follow instructions in the opinion of the Investigator.
1. Patient having infected wound.
2. Those who are having visceral, bony, spinal injury.
3. Patient with electrical, chemical, burn injuries.
4. Patient suffering from any systemic disease like Diabetes mellitus, tuberculosis, malignant wounds, arterial, varicose ulcer, pressure ulcer, HbsAg, HIV I &II positive and others which
according to the investigator can interfere/cause delay in the wound healing process.
5. Patients suffering from non-healing wounds/ulcers, infectious disease will be excluded from the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Healing the wound within 1 to 2 weeks <br/ ><br>2. Pain reduction in 1 to 2 weeks <br/ ><br>3. No secondary infections in 1 to 2 weeks <br/ ><br>4. Assessment of time required (in days) for complete wound healing.Timepoint: Day 1, Day 7, Day 15, Day 22 & Day 29
- Secondary Outcome Measures
Name Time Method To observe safety and skin tolerability throughout the study. <br/ ><br>Timepoint: Day 1, Day 7, Day 15, Day 22 & Day 29